Second-generation colon capsule endoscopy compared with colonoscopy.

Abstract:

BACKGROUND:Colon capsule endoscopy (CCE) represents a noninvasive technology that allows visualization of the colon without requiring sedation and air insufflation. A second-generation colon capsule endoscopy system (PillCam Colon 2) (CCE-2) was developed to increase sensitivity for colorectal polyp detection compared with the first-generation system. OBJECTIVE:To assess the feasibility, accuracy, and safety of CCE-2 in a head-to-head comparison with colonoscopy. DESIGN AND SETTING:Prospective, multicenter trial including 8 European sites. PATIENTS:This study involved 117 patients (mean age 60 years). Data from 109 patients were analyzed. INTERVENTION:CCE-2 was prospectively compared with conventional colonoscopy as the criterion standard for the detection of colorectal polyps that are ≥6 mm or masses in a cohort of patients at average or increased risk of colorectal neoplasia. Colonoscopy was independently performed within 10 hours after capsule ingestion or on the next day. MAIN OUTCOME MEASUREMENTS:CCE-2 sensitivity and specificity for detecting patients with polyps ≥6 mm and ≥10 mm were assessed. Capsule-positive but colonoscopy-negative cases were counted as false positive. Capsule excretion rate, level of bowel preparation, and rate of adverse events also were assessed. RESULTS:Per-patient CCE-2 sensitivity for polyps ≥6 mm and ≥10 mm was 84% and 88%, with specificities of 64% and 95%, respectively. All 3 invasive carcinomas were detected by CCE-2. The capsule excretion rate was 88% within 10 hours. Overall colon cleanliness for CCE-2 was adequate in 81% of patients. LIMITATIONS:Not unblinding the CCE-2 results at colonoscopy; heterogenous patient population; nonconsecutive patients. CONCLUSION:In this European, multicenter study, CCE-2 appeared to have a high sensitivity for the detection of clinically relevant polypoid lesions, and it might be considered an adequate tool for colorectal imaging.

journal_name

Gastrointest Endosc

authors

Spada C,Hassan C,Munoz-Navas M,Neuhaus H,Deviere J,Fockens P,Coron E,Gay G,Toth E,Riccioni ME,Carretero C,Charton JP,Van Gossum A,Wientjes CA,Sacher-Huvelin S,Delvaux M,Nemeth A,Petruzziello L,de Frias CP,Mayershofe

doi

10.1016/j.gie.2011.03.1125

subject

Has Abstract

pub_date

2011-09-01 00:00:00

pages

581-589.e1

issue

3

eissn

0016-5107

issn

1097-6779

pii

S0016-5107(11)01347-2

journal_volume

74

pub_type

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